Olopatadine

Registered South African indications:

• Temporary prevention of itching of the eye associated with allergic conjunctivitis

Contraindications

Registered South African contraindications & Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Concomitant use with soft contact lenses
• Dry eye conditions
• Conditions with compromised corneas

Forms avail. in SA and covered in this monograph: opd

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Temporary prevention of itching of the eye associated with allergic conjunctivitis

1mg/ml

• Ophthalmic (opd): Instil 1 drop into the conjunctival sac of the affected eye(s), twice daily

After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product

2mg/ml

• Ophthalmic (opd): Instil 1 drop into the conjunctival sac of the affected eye(s), once daily

Olopatadine is for ocular use only

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use

In case of concomitant therapy with other topical ocular medicines, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last

Paed. forms avail. in SA and covered in this monograph: opd

Paed. dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Temporary prevention of itching of the eye associated with allergic conjunctivitis

1mg/ml & 2mg/ml

Younger than 3 years

• Not established for use 

Older than 3 years

• See adult dosage

The safety and efficacy of olopatadine 2mg/ml in children aged under 3 years has not been established. No data are available

Pregnancy

• Caution
• There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women
• Studies in animals have shown reproductive toxicity following systemic administration
• Olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception

Breastfeeding

• Caution; not recommended 
• Available data in animals have shown excretion of olopatadine in milk following oral administration
• A risk to the newborn/infants cannot be excluded
• Olopatadine should not be used during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dysgeusia
• Dizziness
• Hypoaesthesia
• Somnolence
• Fatigue

Respiratory Disorders

• Nasal dryness
• Dyspnoea
• Sinusitis
• Rhinitis

Gastrointestinal Disorders

• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Contact dermatitis
• Burning sensation 
• Dry skin
• Dermatitis
• Erythema

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Facial swelling

Sensory Disorders

• Dry eyes
• Corneal epithelium defect
• Punctate keratitis
• Corneal staining 
• Eye discharge
• Photophobia 
• Reduced visual acuity
• Blepharospasm
• Ocular discomfort
• Eye pruritus
• Conjunctival follicles
• Foreign body sensation in eyes 
• Increased lacrimation
• Erythema of eyelid
• Eyelid oedema
• Ocular hyperaemia
• Corneal oedema
• Eye oedema
• Conjunctivitis 
• Mydriasis
• Eyelid margin crusting

No information available

None routine

Olopatadine is a potent selective antihistaminic agent which antagonizes histamine and prevents histamine induced inflammatory cytokine production by conjunctival epithelial cells. Studies suggest that it may act on human mast cells to inhibit the release of pro-inflammatory mediators.

Eye drop (per ml) 1mg

• Patanol (Alcon) originator
• Olopagen (Gen-Eye)